What is API Contract Manufacturing?

What is API Manufacturing

Partnering with the right contractor is one of the most critical decisions a pharmaceutical company can make 

The active pharmaceutical ingredient (API) is the foundation of a final drug product and is a crucial consideration when choosing a Contract Development and Manufacturing Organisation (CDMO). To understand API contract manufacturing, first, it is necessary to understand what is meant by an “active ingredient.”

Also called the “bulk active” or “bulk drug substance,” the API is the part of the drug that produces the intended effect in the diagnosis, cure, mitigation, treatment or prevention of disease or that affects the structure or any function of a human or animal. The term includes those components that may undergo a chemical change and be present in a modified form intended to furnish the specified pharmacological activity in a finished drug product.

An API is formulated with other components that don’t perform the intended chemistry or biochemistry in the body. These components are called “inactive ingredients.”  Active and inactive ingredients are mixed in various dosage forms (such as tablets, capsules or liquids) to yield a drug product.

The manufacture of APIs is a complex, specialised activity, requiring the expert intertwining of chemistry, biology and engineering. For instance, APIs include substances manufactured by a range of processes, including chemical synthesis, fermentation, recombinant DNA or other biotechnology methods, isolation/recovery from natural sources or through any combination of these processes.

Within the pharmaceutical industry, the entire process of making a drug product is either carried out by the owner of the drug, or by engaging a third party or parties (i.e., CDMOs) to complete the whole manufacturing process, or one or more discrete operations, under contract.

Although some companies are hesitant to outsource because of concerns around data security and quality or issues relating to change management, most drug development companies have realized that the return on investment has been worthwhile and that with the right partner, the advantages outweigh the potential risks.

Outsourcing to CDMOs can also provide companies with access to a flexible workforce comprised of highly-specialized experts. Recently, increased outsourcing to CDMOs has been observed for drug owners from biopharma to pharma companies, from small to large firms, and for early to late-stage development projects.

The quality of APIs has a significant effect on the efficacy (producing the result desired) and the safety of medications. Choosing a CDMO that can provide the right API at the required strength, quality and purity is, therefore, a critical decision for drug development companies.

Luina Bio is one of Australia’s most experienced biopharmaceutical CDMOs and is highly cost competitive and extremely flexible, with fast access and turnaround times, and can produce most types of APIs.

Drawing on over 20 years’ experience, the company provides drug development and production services to biopharmaceutical companies, research institutes and veterinary drug clients in America, Asia, Australia and Europe.

Luina Bio holds an Australian Therapeutic Goods Administration license for the manufacture of human therapeutic APIs from both biological and synthetic sources with the resources and expertise to handle all stages of API manufacturing from pre-clinical through phases 1, 2 and 3 of clinical development and to market.

Luina Bio also carries out microbial aerobic and anaerobic fermentation, technical transfer, cell banking, process development and validation, analytical development and can perform cGMP manufacturing of:

  • Recombinant proteins and vaccines
  • Live Biotherapeutics
  • Human and veterinary products
  • Aerobic and fully anaerobic fermentation, BSL-1 BSL-2
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